With the Brexit transition period coming to an end on 31 December 2020, the rules and regulations regarding product self-certification of products made in the UK have changed as well. A new UKCA mark has been introduced by the UK government to replace the existing EU-recognised CE mark.
Depending on what the product is and what market it will be sold on, one or both markings may be required. Below you will find all the relevant information you need to stay compliant with self-certification regulations in the UK after the split from the EU.
UKCA or UK Conformity Assessment marking is a new product marking required for specific products sold in England, Wales and Scotland from January 2021.
UKCA certification signifies that a product has been found to comply with all health, safety and environmental requirements outlined by UK regulations for this specific product type. Most products that previously were CE marked will now need to have a UKCA mark.
Different certifications will be required for products placed on the GB, EU and NI markets. Here’s where the UKCA marks can or cannot be used:
Great Britain: Yes The UKCA mark is recognised in Great Britain only, so it’s applicable only for products sold in England, Wales and Scotland.
EU: No The UKCA marking is not a recognised certification of quality for products sold in the EU. Those will continue to require the relevant CE certification.
Northern Ireland: No The UKCA marking on its own is also not recognised in Northern Ireland. Products sold on the NI market will additionally require the CE marking or UKNI marking.
The UKCA mark officially came into force on 1 January 2021. However, an adjustment period was set out by the UK Government to allow businesses to adapt to the new regulations.
If you have existing stock of products manufactured and CE marked before the end of 2020, you may be able to sell those on the GB market without UKCA marking until the end of 2021.
There are two key dates to remember:
The use of medical devices in Great Britain is subject to an extended courtesy deadline. CE marking will be accepted for those until 30 June 2023.
Some products may be required to have a UKCA marking before January 2023. For that to be the case, all four of the below requirements must be met:
Please note that all of the dates outlined above are dependent on the UK and EU standards and regulations remaining the same during the time period defined above. Significant changes may result in the enforcement of new deadlines for UKCA marking implementation.
As the CE marking and the UKCA marking are subject to similar conformity assessment processes and the standard technical requirements remain largely unchanged, most products that were CE marked will have to be UKCA marked to be sold in England, Scotland or Wales.
Products covered by UKCA include but are not limited to:
Medical devices, civil explosives, construction products and rail interoperability products also require UKCA marking but they are subject to additional rules and regulations.
Self-declaration of conformity for UKCA marking covers various legislative areas. Check the Government website for the full list of covered areas.
UKCA marking will generally have to be placed on the product itself or on the packaging, depending on the specific legislation for the product type.
Usually, the following rules will apply:
From January 2023, the UKCA marks must be permanently attached to the product.
For more information on the subject and the latest updates on the UKCA marking regulations, please visit the Government’s official UKCA guide.
To ensure conformity with UK industry standards and legislation and to be able to prove it to the relevant regulatory bodies you will have to have certain UKCA documentation, including a UK Declaration of Conformity and detailed technical records.
The majority of products that have a UKCA mark must be accompanied by a UK Declaration of Conformity. This is an important legal document which you should be able to present at any point, if required by the relevant market surveillance authorities.
The UK Declaration of Conformity is similar to the EU Declaration of conformity and it usually includes the following information:
Legislative requirements for technical record-keeping vary for different products but generally, you should be able to provide documentation showing key information about:
You must keep all documentation proving that the product is compliant with statutory regulations for up to 10 years after it was made available on the market.
These documents can be requested by any responsible body, be it MSAs of enforcement authorities. Failure to provide those documents may lead to financial losses, including fines, compensations and product discontinuation.
With years of expertise in helping manufacturers ensure international product compliance,RiskMach can help you stay safe and compliant in a post-Brexit economic landscape with the help of our CE and UKCA self-certification software platform, which